GLP PRINCIPLES FOR NAMs
While formal GLP may not apply to all organoid studies, adopting GLP principles enhances regulatory acceptance. Key elements include defined organizational structure, written SOPs, documented training, equipment qualification, test article characterization, and complete audit trails for data integrity.
ESSENTIAL SOPs
- Cell Culture: Thawing, maintenance, passaging, banking, mycoplasma testing
- Model Preparation: Organoid seeding, chip coating, matrix handling
- Compound Handling: Storage, dilution, stability, vehicle preparation
- Assay Execution: Endpoint measurement, controls, acceptance criteria
- Data Management: Recording, review, storage, backup, archival
EQUIPMENT QUALIFICATION
- IQ: Installation qualification—verify proper installation per specifications
- OQ: Operational qualification—verify equipment operates within parameters
- PQ: Performance qualification—verify consistent performance over time
- Calibration: Regular calibration of pipettes, incubators, readers
- Maintenance: Preventive maintenance schedules and documentation
DATA INTEGRITY
Follow ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available. Use electronic lab notebooks with audit trails. Implement 21 CFR Part 11 compliant systems for electronic records. Document all changes with justification—never delete original data.